Inactive

The U.S. Food and Drug Administration (FDA) study “In Vivo Bioequivalence Pharmacokinetic Values of Canine Generic and New Animal Formulations that are not Systemically Absorbed to Validate an In Vitr... The U.S. Food and Drug Administration (FDA) study “In Vivo Bioequivalence Pharmacokinetic Values of Canine Generic and New Animal Formulations that are not Systemically Absorbed to Validate an In Vitro Method for Bioequivalence Assessment” requires 27 Beagles. All 27 beagles need to be acquired at the same time. The study requirements dictate that these dogs be intact males, approximately 7 months of age at the time of acquisition, which translates to approximately 9 kg ± 2 kg at the time of arrival. Additional study requirements are that these dogs be obtained from a vendor that only sells purpose bred animals intended for biomedical research. As part of the approved protocol, these dogs will be adopted out at the conclusion of this study in accordance with HHS and GSA guidelines. Amendment 01 to RFQ_FDA_1232603 for Purchase of Twenty-Seven (27) each Beagles for Animal Study The purpose of this Amendment 01 is to do the following: To provide final responses to the questions received for the RFQ as part of the amendment. See Section B in attachment below for list of questions and responses. To amend RFQ Section 11.8 A. Sub-factor 2 to state: Sub-factor 2 The Offeror shall provide a detailed narrative of the facility addressing the checklist requirements in accordance with the DAVR checklist (Attachment 1). All other terms and conditions outlined in the RFQ remain unchanged. No further questions will be answered.